lisdexamfetamine 40 mg
1 INDICATIONS AND USAGE Lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies ( 14.1 )] Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies ( 14.2 )] . Limitations of Use : Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older [see Use in Specific Populations ( 8.4 )] . Lisdexamfetamine dimesylate chewable tablets are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate chewable tablets for the treatment of obesity have not been established [see Warnings and Precautions ( 5.2 )] . Lisdexamfetamine dimesylate chewable tablets are a central nervous system (CNS) stimulant indicated for the treatment of ( 1 ): Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older Moderate to severe binge eating disorder (BED) in adults Limitations of Use : Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older. ( 8.4 ) Lisdexamfetamine dimesylate chewable tablets are not indicated for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate chewable tablets for the treatment of obesity have not been established. ( 5.2 )
specgx llc
OVAL WHITE M 40
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
LISDEXAMFETAMINE DIMESYLATE Chewable Tablets:
LISDEXAMFETAMINE DIMESYLATE Chewable Tablets 10 mg: round shape, white to off white tablet debossed “M” in a box on one side and 10 on the other Bottles of 100.................................................. NDC 0406-5124-01
LISDEXAMFETAMINE DIMESYLATE Chewable Tablets 20 mg: hexagon shape, white to off white tablet debossed “M” in a box on one side and 20 on the other Bottles of 100.................................................. NDC 0406-5125-01
LISDEXAMFETAMINE DIMESYLATE Chewable Tablets 30 mg: Arc triangle shape, white to off white tablet debossed “M” in a box on one side and 30 on the other Bottles of 100.................................................. NDC 0406-5126-01
LISDEXAMFETAMINE DIMESYLATE Chewable Tablets 40 mg: capsule shape, white to off white tablet debossed “M” in a box on one side and 40 on the other Bottles of 100.................................................. NDC 0406-5127-01
LISDEXAMFETAMINE DIMESYLATE Chewable Tablets 50 mg: Arc square shape, white to off white tablet debossed “M” in a box on one side and 50 on the other Bottles of 100.................................................. NDC 0406-5128-01
LISDEXAMFETAMINE DIMESYLATE Chewable Tablets 60 mg: Arc diamond shape, white to off white tablet debossed “M” in a box on one side and 60 on the other Bottles of 100.................................................. NDC 0406-5129-01 16.2 Storage and Handling Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
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